Prospecto:Information for the Patient

Sildenafilo Tevagen 20 mg Film-Coated Tablets

Read this prospectus carefully before starting to take this medication,because it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult yourdoctor or pharmacist.

-This medication has been prescribedonlyto you, and you should not give it to other people even if they havethe same symptomsas you,as it may harm them.

• If you experience any adverse effects,consult your doctor or pharmacist,evenif they are not listed in this prospectus. See section 4.

1.What is Sildenafilo Tevagen and what is it used for

2.What you need to knowbeforestarting totake Sildenafilo Tevagen

3.How to take Sildenafilo Tevagen

4.Possible adverse effects

5Storage of Sildenafilo Tevagen

6.Contents of the package and additional information

Sildenafilo Tevagen contains the active ingredient sildenafilo which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.

Sildenafilo Tevagen reduces blood pressure in the lungs by dilating the blood vessels in the lungs. Sildenafilo Tevagen is used to treat high blood pressure in the blood vessels of the lung (pulmonary arterial hypertension) in adults and in children and adolescents from 1 to 17 years.

Do not takeSildenafilo Tevagen:

• if you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).

• if you are taking medicines that contain nitrates (such as nicorandil) or donors of nitric oxide such as amyl nitrite (“poppers”). These medicines are often used to relieve chest pain (or angina pectoris).Sildenafilo Tevagenmay increase the effects of these medicines. Inform your doctor if you are taking any of these medicines. If you are unsure, consult your doctor or pharmacist.
• if you are taking riociguat. This medicine is used to treat pulmonary hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs caused by clots). Phosphodiesterase type 5 inhibitors, such assildenafil, have shown to increase the hypotensive effect of this medicine. If you are taking riociguat or are unsure, consult your doctor.
• if you have recently had a stroke, a heart attack, or if you have severe liver disease or very low blood pressure (<90
• if you are taking a medicine to treat fungal infections such as ketoconazole or itraconazole or medicines that contain ritonavir (for HIV).
• if you have previously experienced loss of vision due to a problem with blood flow in an eye nerve called non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Sildenafilo Tevagen if:

• you have a disease due to a blockage or narrowing of a vein in the lungs instead of a blockage or narrowing of an artery.
• you have a serious heart problem.
• you have a problem with the heart's pumping chambers.
• you have high blood pressure in the blood vessels of the lungs.
• you have low blood pressure at rest.
• you lose a large amount of body fluids (dehydration) that can occur when you sweat a lot or do not drink enough liquids. This can happen if you are sick with fever, vomiting, or diarrhea.
• you have a rare inherited eye disease (retinitis pigmentosa).
• you have an abnormality of red blood cells (sickle cell anemia), blood cancer (leukemia), bone marrow cancer (multiple myeloma), or any disease or deformity of the penis.
• you have an active stomach ulcer or bleeding disorders (such as hemophilia) or nosebleeds.
• you are taking medicines for erectile dysfunction.

When phosphodiesterase type 5 inhibitors, including sildenafil, are used to treat erectile dysfunction (ED), the following visual adverse effects have been reported with an unknown frequency: sudden, temporary, or permanent partial or complete loss of vision in one or both eyes.

If you experience a sudden loss of vision,stop taking Sildenafilo Tevagenand inform your doctor immediately(see also section 4).

Prolonged and sometimes painful erections have been observed in men taking sildenafil. If you have an erection that lasts for more than 4 hours,stop taking Sildenafilo Tevagenand consult your doctor immediately(see also section 4).

Special precautions in patients with kidney or liver problems

You should inform your doctor if you have kidney or liver problems, as a dose adjustment may be necessary.

Children

Sildenafilo Tevagen should not be administered to children under 1 year.

Taking Sildenafilo Tevagen with other medicines

Do not take Sildenafilo Tevagen with(see also “Do not take Sildenafilo Tevagen” in this section)

-Medicines that contain nitrates (such as nicorandil) or donors of nitric oxide such as amyl nitrite (“poppers”).

-Medicines that contain riociguat.

-Medicines that contain ketoconazole, itraconazole, or ritonavir.

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

- Medicines that contain substances such as bosentan, ambrisentan, iloprost (for pulmonary hypertension).

- Medicines that belong to the same group as sildenafil (PDE5 inhibitors).

-Medicines that contain St. John's Wort (herbal medicine), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used, among others, to treat epilepsy).

-Medicines that contain erythromycin, clarithromycin, telithromycin (antibiotics used

to treat certain bacterial infections), saquinavir (for HIV) or nefazodone (for depression) as a dose adjustment may be necessary.

-Medicines that contain beta-blockers (a group of medicines used to treat hypertension, heart failure, irregular heart rhythm, migraine).

-Anticoagulant medicines (such as warfarin) although these did not result in any adverse effects.

-Medicines that contain alpha-blockers (such as doxazosin)

for the treatment of hypertension or prostate problems, as the combination of the two medicines may cause symptoms of low blood pressure (such as dizziness, fainting).

• Medicines that containsacubitril/valsartan (medicines used to treat heart failure).

Taking Sildenafilo Tevagen with food and drinks

You should not take grapefruit juice when being treated with Sildenafilo Tevagen.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine. Sildenafilo Tevagen should not be used during pregnancy unless absolutely necessary.

Sildenafilo Tevagen should not be administered to women of childbearing age unless adequate contraceptive methods are used.

Sildenafilo passes into breast milk at very low levels and is not expected to harm your baby.

Driving and operating machines

Sildenafilo Tevagenmay cause dizziness and affect your vision. You should know how you react to this medicine before driving vehicles or operating machinery.

Sildenafilo Tevagen contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per coated tablet; that is, it is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor.This medicationindicated by your doctor.Consult your doctor or pharmacist again if you are unsure.

For adults, the recommended dose is 20 mg three times a day (taken at intervals of 6 to 8 hours) taken with or without food.

Use in children and adolescents

For children and adolescents from 1 to 17 years, the recommended dose is 10 mg three times a day for children and adolescents ≤ 20 kg or 20 mg three times a day for children and adolescents > 20 kg, administered with or without food. In children, do not use higher doses than recommended. This medication should only be used for cases where 20 mg three times a day should be administered. For administration in patients ≤ 20 kg and in other younger patients who cannot swallow the tablets, other more suitable pharmaceutical forms may be used.

If you take more Sildenafilo Tevagen than you should

Do not take more medication than your doctor indicates.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, telephone 91 562 04 20, indicating the medication and the amount ingested.

Taking more Sildenafilo Tevagen than you should may increase the risk of known adverse effects.

If you forgot to take Sildenafilo Tevagen

If you have forgotten to take Sildenafilo Tevagen, take the dose as soon as you remember and continue taking your medication at regular hours. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Sildenafilo Tevagen

Stopping treatment with Sildenafilo Tevagen suddenly may lead to worsening of your symptoms. Do not stop taking Sildenafilo Tevagen unless your doctor tells you to. Your doctor will instruct you on how to reduce the dose over a few days before stopping it completely.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you experience any of the following side effects, stop taking Sildenafilo Tevagen and inform your doctor immediately (see also section 2):

- if you experience a sudden reduction or loss of vision (unknown frequency).

- if you have an erection that lasts for more than 4 hours. Prolonged and sometimes painful erections have been reported after taking sildenafilo in men (unknown frequency).

Adults

The side effects reported very frequently (may affect more than 1 in 10 people) were, headache or facial flushing, indigestion, diarrhea, and pain in arms and legs.

The side effects reported frequently (may affect up to 1 in 10 people) are: skin infection, flu-like symptoms, nasal congestion, reduction in red blood cell count (anemia), fluid retention, difficulty sleeping, anxiety, migraine, tremor, tingling sensation, burning sensation, reduced sense of touch, bleeding from the back of the eye, visual disturbances, blurred vision, and light sensitivity, color perception effects, eye irritation, red or bloodshot eyes, dizziness, bronchitis, nasal bleeding, runny nose, cough, stuffy nose, stomach inflammation, gastroenteritis, burning sensation, hemorrhoids, abdominal distension, dry mouth, hair loss, skin redness, night sweats, muscle pain, back pain, and increased body temperature.

The side effects reported infrequently (may affect up to 1 in 100 people) included: reduced visual acuity, double vision, abnormal sensation in the eye, penile bleeding, presence of blood in semen and/or urine, and breast enlargement in men.

Also, skin eruptions, sudden decrease or loss of hearing, and reduced blood pressure have been reported with an unknown frequency (the frequency cannot be estimated with the available data).

Children and adolescents

Frequent (may affect up to 1 in 10 people) severe side effects reported in children and adolescents were: pneumonia, heart failure, right heart failure, cardiac shock, high blood pressure in the lungs, chest pain, dizziness, respiratory infection, bronchitis, viral infection in the stomach and intestines, urinary tract infections, and tooth perforations.

The following severe side effects were considered related to treatment and were reported infrequently (may affect up to 1 in 100 people): allergic reaction (such as skin rash, facial, lip, and tongue inflammation, sneezing, difficulty breathing or swallowing), convulsions, irregular heartbeat, hearing disturbances, shortness of breath, digestive tract inflammation, and sneezing due to airway flow alterations.

The side effects reported very frequently (may affect more than 1 in 10 people) were headache, vomiting, throat infection, fever, diarrhea, flu, and nasal bleeding.

The side effects reported frequently (may affect up to 1 in 10 people) were nausea, increased erections, pneumonia, and runny nose.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe boxafter CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and unused medications at the SIGRE collection pointat the pharmacy. If in doubtask your pharmacisthow to dispose ofthepackaging and unusedmedications.By doing so, you will help protect the environment.

Composition of Sildenafilo Tevagen

• The active ingredient is sildenafilo. Each tablet contains 20 mg of sildenafilo (as citrato).
• The otherexcipientsare:

Tablet core: microcrystalline cellulose, calcium hydrogen phosphate, croscarmellose sodium, magnesium stearate.

Coating: hypromellose, macrogol 6000, talc, titanium dioxide (E171).

Appearance of the product and contents of the package

Sildenafilo Tevagen 20 mg tablets are white or almost white, approximately 6.5 mm in diameter, biconvex, round, marked with “20” on one face and smooth on the other.

Sildenafilo Tevagen 20 mg film-coated tablets are available in blister or perforated single-dose blister PVC/PVdC-Aluminium of 30, 90, 90x1 or 300 film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

c/ Anabel Segura, 11 Edificio Albatros B, 1st Floor

Alcobendas 28108 Madrid (Spain)

Responsible manufacturer

Teva Operations Poland Sp. z.o.o

ul. Mogilska 80, Kraków 31-546

Poland

Ó

Merckle GmbH

Ludwig-Merckle-Strasse 3, Blaubeuren, 89143

Germany

Ó

PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)

Prilaz baruna Filipovica 25, Zagreb 10000

Croatia

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:January 2023

Further information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es/